K Number
K024199
Device Name
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
Date Cleared
2003-03-14

(84 days)

Product Code
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Device Description
The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes. The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
More Information

Not Found

No
The summary describes a resorbable surgical film made of polymer, with no mention of AI or ML in its intended use, device description, or performance studies.

Yes
The device is used to reinforce soft tissue, repair hernias, and address other fascial defects, which are therapeutic interventions.

No

Explanation: The device, IMMIX™ Thin Film, is described as a material for temporary wound support, reinforcing soft tissue, and repairing defects. Its function is to physically support or bridge tissues, not to diagnose medical conditions by analyzing data or images.

No

The device description clearly states it is a physical product made of polymer, provided in sheets, and intended for surgical implantation. It is a physical medical device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device for surgical implantation to provide temporary wound support, reinforce soft tissue, and repair hernias or fascial defects. This is a therapeutic and structural function within the body.
  • Device Description: The description details a physical implantable material made of poly(D,L-lactide-coglycolide) polymer, provided in sheets with specific dimensions and features (holes, thickness). This is consistent with a surgical implant.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze biological samples.

The device described is a surgical implant used in vivo (within the body) for structural support and repair.

N/A

Intended Use / Indications for Use

The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Product codes (comma separated list FDA assigned to the subject device)

79FTL, FTL

Device Description

The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.

The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue, hernia, fascial defects, vaginal, colon, rectal, pelvic floor

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility assessment performed by an independent certified laboratory Testing: demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. OsteoBiologics performed suture pullout testing on a family of thin film products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ Thin Film for use in a clinical situation.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K012025

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.

0

K024199

MAR 1 4 2003

510(k) SUMMARY

SubmitterContact
OsteoBiologics, Inc.Gabriele G. Niederauer, Ph.D.
12500 Network, Suite 112Director of Research and Development
San Antonio, Texas 78249Phone: 210-690-2131 (ext. 228)
USAFax: 210-690-2559
E-mail: gabi@obi.com
Date of Summary:December 19, 2002
Common Name:Polymeric Surgical Mesh
Proprietary Name:IMMIX™ Thin Film
Device Classification:Polymeric surgical mesh (Product Code 79FTL) is a Class I
prosthetic device, per 21 CFR §878.3300
510(k) Number:K024199

Description of Device: The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.

The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.

Intended Use: The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Substantial Equivalence: The IMMIX™ Thin Film is substantially equivalent in design, function and intended use to the MacroPore Surgi-Wrap (TS), cleared as K012025 on December 3, 2001.

Biocompatibility assessment performed by an independent certified laboratory Testing: demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. OsteoBiologics performed suture pullout testing on a family of thin film products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ Thin Film for use in a clinical situation.

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

MAR 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OsteoBiologics, Inc. Gabriele G. Niederauer, Ph.D. Director of Research and Development University Business Park 12500 Network, Suite 112 San Antonio. Texas 78249-3308

Re: K024199

Trade/Device Name: IMMIX™ Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M Regulation Number: 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: Class II Product Code: FTL Dated: December 19, 2002 Received: December 20, 2002

Dear Dr. Niederauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

2

Page 2 - Dr. Gabriele G. Niederauer

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

tol Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

INDICATIONS FOR USE
510(k) Number (if known):K024199
Device Name:IMMIX™ Thin Film
Indications For Use:The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) NumberK024199
Prescription Use
(Per 21 CFR 801.109)OR Over-The-Counter Use

: